Set to roll out the U.S. market's first prescription cannabidiol soon, GW Pharmaceutical will be looking to assure doctors that Epidiolex, approved to treat rare forms of epilepsy, is vastly different from off-the-shelf artisan oils at cannabis shops.
To that end, GW has hired 66 neurology sales representatives who will target some 5,000 epilepsy specialists in the U.S., Stephen Schultz, VP of investor relations, said. Their message? Trust the science and rigor behind the only FDA-approved CBD.
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“We’re the leader in this area, we’re science-based, and we believe physicians and patients will desire medicines that have gone through the FDA review process. When a drug is prescribed that’s FDA approved, you know it’s exactly the same every time it’s prescribed and every time it’s taken,” Schultz said.
Epidiolex was initially approved in June, but it had to wait until last week for the Drug Enforcement Agency to figure out how to handle the plant-derived cannabidiol CBD. The good news for GW was a rescheduling from a Schedule I drug—others in that class include heroin and marijuana—to a Schedule V, the class considered to have the least potential for abuse. That class includes medicines such as Robitussin AC and Pfizer's Lyrica.
Two websites, one directed at physicians and the other at patients, will back the launch, although Schultz characterized the marketing as a “medically oriented education commercialization effort” directed at professionals.
Along with the launch of Epidiolex to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome epilepsies, GW plans to continue to trial the drug for other uses. It currently has a single phase 2 study, due to read out next year, testing the drug as a treatment for seizures in tuberous sclerosis complex.
Schultz said GW’s own clinical experience also suggests promise for Epidiolex for treatment of autism spectrum disorders, and the company plans to launch a new study in Rett Syndrome in the fourth quarter.